Type 1 diabetes mellitus
Conditions
Interventions
Product Name: NN1250
Product Code: NN1250
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Insulin degludec
CAS Number: 844439-96-9
Current Sponsor code: NNC 0100-0000-0454
Concentrati
Sponsors
Novo Nordisk A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Informed consent obtained before any trial-related activities. (Trial-related activities are defined as any procedure that would not have been performed during normal management of the subject) • The subject must have completed the six-month treatment period (Visit 28) in trial NN1250-3585 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Anticipated change in concomitant medication known to interfere significantly with glucose metabolism, such as systemic corticosteroids, beta-blockers, monoamine oxidase (MAO) inhibitors • Anticipated significant lifestyle changes during the trial, e.g. shift work (including permanent night/evening shift workers), as well as highly variable eating habits as judged by the investigator • Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements (for United Kingdom: Adequate contraceptive measures are defined as established use of oral, injected or implanted hormonal methods of contraception, sterilisation, intrauterine device or intrauterine system, or consistent use of barrier methods) • Previous participation in this trial. Participation is defined as having performed any trial-related activities
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to investigate the long-term safety and tolerability of NN1250 in combination with insulin aspart. This is done by comparing NN1250 to insulin detemir, both in combination with insulin aspart after 52 weeks of treatment (26 weeks of treatment in trial NN1250-3585 plus 26 weeks of treatment in this extension trial) in terms of the listed safety assessments from which endpoints will be calculated: • Adverse events (AEs) • Hypoglycaemic episodes • Clinical evaluations • Laboratory assessments • Insulin dose • Body weight;Secondary Objective: The secondary objective is to compare the efficacy between SIBA and insulin detemir, both in combination with insulin aspart after 52 weeks of treatment in terms of the listed efficacy assessments from which endpoints will be calculated: • HbA1c (glycosylated haemoglobin) at a central laboratory • Fasting plasma glucose (FPG) measured at a central laboratory • 9-point self measured plasma glucose(SMPG) profile • 4-point self-measured plasma glucose (SMPG) profile;Primary end point(s): • Number of treatment emergent adverse events (TEAEs) with an onset on or after the first day of exposure to randomised trial drug and no later than 7 days after last exposure to randomised trial drug • Number of severe and minor treatment emergent hypoglycaemic episodes with an onset on or after the first day of exposure to randomised trial drug and not later than 7 days after last exposure to randomised trial drug • Insulin454 specific antibodies | — |
Countries
Finland, Italy, United Kingdom
Outcome results
None listed